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  • CLASSES

    Androstan Derivatives

    BOXED WARNING

    Hepatic disease, new primary malignancy, peliosis hepatis, tumorigenicity

    Use is contraindicated in patients with severe hepatic disease or dysfunction. Peliosis hepatis, some cases resulting in life-threatening liver failure, has been reported. Liver tumorigenicity, including benign tumors and fatal malignant tumors (e.g., new primary malignancy), has also been reported. Discontinue oxymetholone in patients who develop peliosis hepatitis, liver cell tumors, or signs of hepatic dysfunction as withdrawal of the agent may resolve the condition. Due to the potential for hepatotoxicity, obtain liver function tests periodically.

    Hypercholesterolemia, hyperlipidemia

    Decreased high density lipoprotein and increased low density lipoprotein (hyperlipidemia and hypercholesterolemia) may occur with androgens and anabolic steroids, such as oxymetholone, and may increase the risk of atherosclerosis and coronary artery disease.

    DEA CLASS

    Rx, schedule III

    DESCRIPTION

    Oral anabolic steroid
    Approved for the treatment of anemias caused by deficient red cell production; used off-label for HIV-associated wasting
    Black box warning for hyperlipidemia, peliosis hepatis (some cases leading to liver failure), and fatal malignant liver cell tumors

    COMMON BRAND NAMES

    Anadrol

    HOW SUPPLIED

    Anadrol Oral Tab: 50mg

    DOSAGE & INDICATIONS

    For the treatment of anemia caused by deficient red cell production, including aplastic anemia (acquired and congenital), myelofibrosis, and hypoplastic anemia due to myelotoxic drugs.
    Oral dosage
    Children, Adolescents, and Adults

    1—2 mg/kg/day orally is the usual effective dosage in children and adults; however, oxymetholone therapy should be individualized and a higher dosage may be necessary (up to 5 mg/kg/day). Because response may be delayed, a minimum of 3—6 months of therapy is recommended. Once remission is achieved, therapy may be discontinued or decreased in some patients. Patients with congenital aplastic anemia usually require maintenance therapy.

    For the treatment of AIDS-associated wasting syndrome†.
    Oral dosage
    Adults

    50 mg orally twice daily for up to 32 weeks resulted in a 5.3% increase in total weight gain from baseline in patients with HIV and weight loss in a randomized, double-blind, placebo-controlled, phase III study. Eugonadal HIV patients (male, n = 79; female, n = 10) who were receiving highly active antiretroviral therapy for more than 3 months and had experienced a weight loss of at least 5% in the previous 6 months or were 10% below ideal body weight in the previous 12 months were randomized to receive treatment with oxymetholone 50 mg twice daily (n = 30) or oxymetholone 50 mg 3 times daily (n = 31) or matching placebo given 2 or 3 times daily (n = 28) for 16 weeks; 72 of these patients then received an additional 16 weeks of oxymetholone 50 mg twice daily in an open-label maintenance phase. In patients who received oxymetholone therapy,the onset of weight gain started within 4 weeks and resulted in a total weight gain of up to 3.5 kg (twice daily dosing, 3.5 +/- 0.7 kg; 3 times daily dosing, 3 +/- 0.5 kg; placebo, 1 +/- 0.7 kg). Additionally, lean body mass was increased by 2.9 +/- 0.54 kg with twice daily oxymetholone compared with 1.8 +/- 0.8 kg with 3 times daily oxymetholone dosing (p < 0.0001). Serious liver related side effects were reported with oxymetholone therapy including elevated liver enzymes, jaundice, hepatomegaly, and hyperbilirubinemia.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    5 mg/kg/day PO.

    Geriatric

    5 mg/kg/day PO.

    Adolescents

    5 mg/kg/day PO.

    Children

    5 mg/kg/day PO.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available.

    ADMINISTRATION

    Oral Administration
    Oral Solid Formulations

    Oxymetholone should be titrated and individualized from the initial recommended dosage (see Dosage).

    STORAGE

    Anadrol:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Anabolic steroids, such as oxymetholone, may suppress clotting factors II, V, VII, and X and increase prothrombin time.

    Breast cancer, prostate cancer

    Oxymetholone is contraindicated in male patients with breast cancer or prostate cancer. It is also contraindicated in female patients with breast cancer and hypercalcemia because androgenic anabolic steroids may stimulate osteolytic resorption of bone. Monitoring of urine and serum calcium levels is recommended in women with disseminated breast cancer.

    Hepatic disease, new primary malignancy, peliosis hepatis, tumorigenicity

    Use is contraindicated in patients with severe hepatic disease or dysfunction. Peliosis hepatis, some cases resulting in life-threatening liver failure, has been reported. Liver tumorigenicity, including benign tumors and fatal malignant tumors (e.g., new primary malignancy), has also been reported. Discontinue oxymetholone in patients who develop peliosis hepatitis, liver cell tumors, or signs of hepatic dysfunction as withdrawal of the agent may resolve the condition. Due to the potential for hepatotoxicity, obtain liver function tests periodically.

    Renal disease

    Oxymetholone is contraindicated in patients with active renal disease, specifically, nephrosis or the nephrotic stage of nephritis. Patients with pre-existing cardiac, renal, or hepatic disease may develop edema with or without congestive heart failure with oxymetholone therapy.

    Hypercholesterolemia, hyperlipidemia

    Decreased high density lipoprotein and increased low density lipoprotein (hyperlipidemia and hypercholesterolemia) may occur with androgens and anabolic steroids, such as oxymetholone, and may increase the risk of atherosclerosis and coronary artery disease.

    Diabetes mellitus

    Androgen therapy (such as oxymetholone) can result in loss of diabetic control and should be used with caution in patients with diabetes mellitus. Close monitoring of blood glucose is recommended.

    Females

    Females are at risk for virilization (e.g., voice deepening, hirsutism, acne, clitoromegaly) and menstrual irregularities (e.g., amenorrhea) with androgen anabolic steroid use. Some cases of virilization are irreversible after stopping therapy and concomitant estrogen therapy may not prevent this condition.

    Geriatric

    Male geriatric patients who receive androgenic anabolic steroids may be at increased risk for developing prostate hypertrophy and prostate cancer.

    Children, infants, neonates

    Androgenic anabolic steroids such as oxymetholone should be used with caution in children because of the potential for adverse effects on bone maturation. These agents may accelerate epiphyseal maturation more rapidly than linear growth in children, an effect that may continue for 6 months after therapy discontinuation. Monitor X-ray scans every 6 months if oxymetholone therapy is used in children. The safety and efficacy in infants and neonates has not been established.

    Pregnancy

    Oxymetholone is classified as FDA pregnancy category X. Fetal harm can occur and use is contraindicated in pregnant women or in women who may become pregnant while on therapy. Women who become pregnant during therapy should be appraised of the potential risk to the fetus. Additionally, impairment of fertility is possible with oxymetholone therapy; oligospermia may occur in males and amenorrhea may occur in females.

    Breast-feeding

    According to the manufacturer, it is not know whether anabolic steroids, including oxymetholone, are excreted in human milk. Women who are taking oxymetholone should avoid breast-feeding due to the potential for serious adverse reactions in a nursed infant, including accelerated epiphyseal maturation of bone. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    hepatic necrosis / Delayed / Incidence not known
    epididymitis / Delayed / Incidence not known
    clitoromegaly / Delayed / Incidence not known
    new primary malignancy / Delayed / Incidence not known
    hyperkalemia / Delayed / Incidence not known

    Moderate

    peliosis hepatis / Delayed / Incidence not known
    elevated hepatic enzymes / Delayed / Incidence not known
    jaundice / Delayed / Incidence not known
    testicular atrophy / Delayed / Incidence not known
    infertility / Delayed / Incidence not known
    impotence (erectile dysfunction) / Delayed / Incidence not known
    priapism / Early / Incidence not known
    excitability / Early / Incidence not known
    anemia / Delayed / Incidence not known
    polycythemia / Delayed / Incidence not known
    tumorigenicity / Delayed / Incidence not known
    dysphonia / Delayed / Incidence not known
    hyperphosphatemia / Delayed / Incidence not known
    hypercalcemia / Delayed / Incidence not known
    edema / Delayed / Incidence not known
    hyperchloremia / Delayed / Incidence not known
    sodium retention / Delayed / Incidence not known
    hyperlipidemia / Delayed / Incidence not known

    Mild

    libido decrease / Delayed / Incidence not known
    menstrual irregularity / Delayed / Incidence not known
    decreased ejaculate volume / Delayed / Incidence not known
    libido increase / Delayed / Incidence not known
    bladder discomfort / Early / Incidence not known
    penile enlargement / Delayed / Incidence not known
    oligospermia / Delayed / Incidence not known
    nausea / Early / Incidence not known
    vomiting / Early / Incidence not known
    diarrhea / Early / Incidence not known
    insomnia / Early / Incidence not known
    gynecomastia / Delayed / Incidence not known
    hirsutism / Delayed / Incidence not known
    alopecia / Delayed / Incidence not known
    acne vulgaris / Delayed / Incidence not known
    muscle cramps / Delayed / Incidence not known
    chills / Rapid / Incidence not known

    DRUG INTERACTIONS

    Abarelix: (Major) Concomitant use of androgens or estrogens with abarelix is relatively contraindicated, as both could counteract the therapeutic effect of abarelix.
    Acarbose: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Alogliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Alogliptin; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Alogliptin; Pioglitazone: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Alpha-glucosidase Inhibitors: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Azelastine; Fluticasone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Beclomethasone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Betamethasone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Budesonide: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Budesonide; Formoterol: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Budesonide; Glycopyrrolate; Formoterol: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Canagliflozin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Canagliflozin; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Ciclesonide: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Corticosteroids: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Cortisone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Cyclosporine: (Moderate) Androgens may increase concentrations of cyclosporine, potentially increasing the risk of nephrotoxicity. Until further data are available, close monitoring of cyclosporine serum concentrations is prudent during coadministration with androgens.
    Dapagliflozin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Dapagliflozin; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Dapagliflozin; Saxagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Darbepoetin Alfa: (Moderate) Androgens are known to stimulate erythropoiesis. Concurrent administration of androgens can increase the patient's response to darbepoetin alfa, reducing the amount required to treat anemia.
    Deflazacort: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Degarelix: (Major) Concomitant use of androgens with degarelix is relatively contraindicated, as androgens could counteract the therapeutic effect of degarelix.
    Dexamethasone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Dipeptidyl Peptidase-4 Inhibitors: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Empagliflozin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Empagliflozin; Linagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Empagliflozin; Linagliptin; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Empagliflozin; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Epoetin Alfa: (Moderate) Androgens are known to stimulate erythropoiesis. Concurrent administration of androgens can increase the patient's response to epoetin alfa, reducing the amount required to treat anemia. Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Further evaluation of this combination needs to be made.
    Ertugliflozin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Ertugliflozin; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Ertugliflozin; Sitagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Fludrocortisone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Flunisolide: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Fluticasone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Fluticasone; Salmeterol: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Fluticasone; Umeclidinium; Vilanterol: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Fluticasone; Vilanterol: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Formoterol; Mometasone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Glipizide; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Glyburide; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Goserelin: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
    Histrelin: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as histrelin. Histrelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
    Hydrocortisone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Incretin Mimetics: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Insulins: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Leuprolide: (Major) Leuprolide inhibits steroidogenesis. While no drug interactions have been reported with leuprolide, therapy with androgens would be relatively contraindicated and would counteract the therapeutic effect of leuprolide.
    Leuprolide; Norethindrone: (Major) Leuprolide inhibits steroidogenesis. While no drug interactions have been reported with leuprolide, therapy with androgens would be relatively contraindicated and would counteract the therapeutic effect of leuprolide.
    Linagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Linagliptin; Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Meglitinides: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Metformin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Metformin; Pioglitazone: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Metformin; Repaglinide: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Metformin; Rosiglitazone: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Metformin; Saxagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Metformin; Sitagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Methoxy polyethylene glycol-epoetin beta: (Moderate) Androgens are known to stimulate erythropoiesis. Despite the fact that endogenous generation of erythropoietin is depressed in patients with chronic renal failure, other tissues besides the kidney can synthesize erythropoietin, albeit in small amounts. Concurrent administration of androgens can increase the patient's response to MPG-epoetin beta, reducing the amount required to treat anemia. Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Further evaluation of this combination needs to be made.
    Methylprednisolone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Miglitol: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Mometasone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Nafarelin: (Major) Gonadotropin releasing hormone (GnRH) agonists (i.e.,nafarelin) inhibit steroidogenesis, therefore the concomitant use of these agents with androgens may counteract this therapeutic effect. Avoid concurrent use of androgens with GnRH agonists.
    Pramlintide: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Prednisolone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Prednisone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Saw Palmetto, Serenoa repens: (Major) Drug interactions with Saw palmetto, Serenoa repens have not been specifically studied or reported. Saw palmetto extracts appear to have antiandrogenic effects. The antiandrogenic effects of Saw palmetto, Serenoa repens would be expected to antagonize the actions of androgens; it would seem illogical for patients taking androgens to use this herbal supplement.
    Saxagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    SGLT2 Inhibitors: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Simvastatin; Sitagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Sitagliptin: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Sulfonylureas: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Thiazolidinediones: (Moderate) Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together.
    Triamcinolone: (Moderate) Concomitant use of oxymetholone with corticosteroids or corticotropin, ACTH may cause increased edema. Manage edema with diuretic and/or digitalis therapy.
    Triptorelin: (Major) Gonadotropin releasing hormone (GnRH) agonists (i.e.,triptorelin) inhibit steroidogenesis, therefore the concomitant use of these agents with androgens may counteract this therapeutic effect. Avoid concurrent use of androgens with GnRH agonists.
    Warfarin: (Moderate) Concomitant use of anabolic steroids such as oxymetholone and oral anticoagulants such as warfarin may increase INR or prothrombin time (PT) and the anticoagulant dosage may need to be decreased. Anabolic steroids may suppress clotting factors II, V, VII, and X and increase PT. In patients receiving warfarin, closely monitor the INR and PT when initiating oxymetholone therapy or when subsequently changing the dosage or discontinuing oxymetholone therapy; adjust the warfarin dose as necessary to maintain a therapeutic INR and PT. Monitor patients for signs and symptoms of bleeding.

    PREGNANCY AND LACTATION

    Pregnancy

    Oxymetholone is classified as FDA pregnancy category X. Fetal harm can occur and use is contraindicated in pregnant women or in women who may become pregnant while on therapy. Women who become pregnant during therapy should be appraised of the potential risk to the fetus. Additionally, impairment of fertility is possible with oxymetholone therapy; oligospermia may occur in males and amenorrhea may occur in females.

    According to the manufacturer, it is not know whether anabolic steroids, including oxymetholone, are excreted in human milk. Women who are taking oxymetholone should avoid breast-feeding due to the potential for serious adverse reactions in a nursed infant, including accelerated epiphyseal maturation of bone. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Oxymetholone is an anabolic steroid with androgenic properties. Oxymetholone stimulates the production and urinary excretion of erythropoietin in anemias due to bone marrow failure and promotes erythropoiesis in anemias caused by deficient red cell production. Oxymetholone may also promote weight gain due to its androgenic effects and has been useful in treating HIV-associated wasting.

    PHARMACOKINETICS

    At the time of review, no pharmacokinetic information for oxymetholone was available from the manufacturer.